Continuous administration of local anesthetic for pain after amputation above knee

Periferal local anesthetic infusion for postoperative pain after above knee amputation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003807-20-FI

Enrollment

180

Registered

2014-02-04

Start date

2014-02-28

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain after amputation above knee MedDRA version: 16.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Naropin Product Name: Naropin Pharmaceutical Form: Injection Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients presenting for above knee amputation for artheroschlerosis willing to participate, able to give informed consent, able to asses pain using verbal rating scale and assessed to be medically stable so that life expectancy exceeds two weeks as assessed by recruiting anesthesiologist. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Allergy to amide local anesthetics, operating surgeon unable to insert the catheter as defined in the protocol, planned epidural postoperative pain management.

Design outcomes

Primary

Measure	Time frame
Main Objective: Does periferal ropivacaine infusion reduce pain after above knee amputation in patients with atheros sclerosis obliterans;Secondary Objective: Does periferal ropivacaine infusion reduce opioid consumption and opioid reverse affects and prolonged postoperative pain after above knee amputation in patients with atheros sclerosis obliterans;Primary end point(s): Pain on VRS 0-4.;Timepoint(s) of evaluation of this end point: Days 1-5 after operation.	—

Measure

Time frame

Main Objective: Does periferal ropivacaine infusion reduce pain after above knee amputation in patients with atheros sclerosis obliterans;Secondary Objective: Does periferal ropivacaine infusion reduce opioid consumption and opioid reverse affects and prolonged postoperative pain after above knee amputation in patients with atheros sclerosis obliterans;Primary end point(s): Pain on VRS 0-4.;Timepoint(s) of evaluation of this end point: Days 1-5 after operation.

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Secondary

Measure	Time frame
Secondary end point(s): Pain on the amputated limb (stump) 1, 3 and 12 months after operation and amputation phantom limb pain 1-5 days after operation and 1,3 and 12 months after operation on VRS scale 0-4, the consumption of opioid 1-5 days after operation and adverse events ( wound infections, re-operations, and other significant adverse events).;Timepoint(s) of evaluation of this end point: Pain on the amputated limb (stump) 1, 3 and 12 months after operation and amputation phantom limb pain 1-5 days after operation and 1,3 and 12 months after operation on VRS scale 0-4, the consumption of opioid 1-5 days after operation and adverse events ( wound infections, re-operations, and other significant adverse events).	—

Measure

Time frame

Secondary end point(s): Pain on the amputated limb (stump) 1, 3 and 12 months after operation and amputation phantom limb pain 1-5 days after operation and 1,3 and 12 months after operation on VRS scale 0-4, the consumption of opioid 1-5 days after operation and adverse events ( wound infections, re-operations, and other significant adverse events).;Timepoint(s) of evaluation of this end point: Pain on the amputated limb (stump) 1, 3 and 12 months after operation and amputation phantom limb pain 1-5 days after operation and 1,3 and 12 months after operation on VRS scale 0-4, the consumption of opioid 1-5 days after operation and adverse events ( wound infections, re-operations, and other significant adverse events).

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026